Stitching Platform with Handles/ Clear Stitching Stand

Primary DI
00860001700169
Brand
Stitching Platform with Handles/ Clear Stitching Stand
Company
Reina Imaging
Model
CSS[X]; SPH-F
Device description
Designed as a patient stabilizer for use when taking a radiograph requiring stitching software. The device provides a stepping platform for the patient and a clear polycarbonate back that allows a radiology technologist to position the device centered to the image receptor, facilitating patient positioning.
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXHCradle, Patient, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXHCradle, Patient, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001700169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001700169008600017001698600017001690860001700169

GMDN Terms#

Term, Definition table
TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8153568181treina@reinaimaging.com

Regulatory Flags#

DUNS number
102370137
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001700107Collim-AidCA22023-06-08
00860001700176Weight Bearing DRP HoldersWDDR[X]2023-06-08
00860001700121Trans-Former[T][#]-[Z]Digital Detector Holder2019-10-29
00860001700183Protect-A-GridP[2][X]DR[NG][Y]Premium Grid Encasement 2019-10-29

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